Determination of the preventive effect of cyproheptadine in preventing headache and hypotension in spinal anesthesia
Design
A single-blind control clinical trial with parallel and randomized groups sealed by the envelope will be performed on 56 patients in Phase 2.
Settings and conduct
In the current interventinal study, which Will be carried out as a single-blind clinical trial, 56 patients undergoing spinal anesthesia at Khatam Al-Anbia Hospital in Shahroud in 1400 and 1401 will be randomly selected. Individuals are randomly divided into one of two groups receiving ciproheptadine (4 mg single dose) or placebo (single-dose ciproheptadine placebo tablets). Follow-up in the field of headache and hypotension will be done for 24 to 48 hours after the operation and the frequency of headache and hypotension in the two groups will be determined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: surgery under spinal anesthesia, elective surgery, and American Society of Anesthesiologists (ASA) class I.
Exclusion criteria: unwillingness of patients to cooperate, underlying diseases, and emergency surgeries.
Intervention groups
The intervention groups included the ciproheptadine group (receiving ciproheptadine tablets at a dose of 4 mg as a single oral dose) and the placebo group (receiving a single-dose placebo ciproheptadine tablet).
Main outcome variables
Headache and hypotension
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211218053439N1
Registration date:2022-02-22, 1400/12/03
Registration timing:registered_while_recruiting
Last update:2022-02-22, 1400/12/03
Update count:0
Registration date
2022-02-22, 1400/12/03
Registrant information
Name
Zahra Farhadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3220 1378
Email address
safa75967596@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preventive effect of cyproheptadine in preventing headache and hypotension in spinal anesthesia in patients undergoing spinal anesthesia
Public title
Effect of cyproheptadine on headache and hypotension after spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Surgery under spinal anesthesia
Elective surgery
American Society of Anesthesiologists(ASA) class I
Age between 20 and 70 years
Exclusion criteria:
Reluctance to participate in the study
Having any underlying disease
Emergency surgery
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Our aim is to categorize the subjects in two separate groups; A(cyproheptadine) and B(control). To achieve this goal, 4 blocks Will be randomly chosen; AABB, BABA, BAAB, BBAA, which will each be put in a packet afterwards, so that selection of each packet is equally random. For the first 4 participants a block will randomly chosen and selection of the remaining will follow the rule.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants, who are fully informed about the study, will not be cognisant of whether they are receiving cyproheptadine or placebo, whereas the research crew including the physician, the nurse, the person responsible for collecting data, the researcher, and the person preparing the draft article and the Safety and Data Monitoring Committee will be aware of the type of medication applied.
It is worth mentioning that we will use placebo for blinding in this study. The placebo will be prepared exactly the same as the main drug(cyproheptadine) in terms of both colour and shape, with the cooperation of one of the pharmacy universities. Afterwards, they will be given to the participants.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University - Shahrood Branch
Street address
Islamic Azad University of Shahroud, University Blvd., Shahroud
City
Shahrood
Province
Semnan
Postal code
3619943189
Approval date
2021-02-06, 1399/11/18
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1399.077
Health conditions studied
1
Description of health condition studied
Spinal anesthesia induced headache and hypotension
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Spinal anesthesia-induced headache
Timepoint
Evaluation of headache at the beginning of the study (before surgery) and 24 and 48 hours after surgery
Method of measurement
Through questionnaire
2
Description
Spinal anesthesia-induced hypotension
Timepoint
Measurement of blood pressure at the beginning of the study (before surgery) and 24 and 48 hours after surgery
Method of measurement
Blood pressure monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving cyproheptadine tablets with a dose of 4 mg and single dose orally
Category
Treatment - Drugs
2
Description
Control group: receiving single-dose ciproheptadine placebo tablets orally
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Al-Anbia Hospital
Full name of responsible person
Yosef Kolokhi
Street address
Khatam Al-Anbia Hospital, University Blvd
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3222 7087
Email
dryousefkolookhianestezi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Behroz Yahyaii
Street address
Islamic Azad University of Shahroud, University Blvd
City
Shahrood
Province
Semnan
Postal code
36199-43189
Phone
+98 23 3220 1452
Email
sabafarhadi9675@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Farhadi
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Islamic Azad University of Shahroud, University Blvd
City
Shahrood
Province
Semnan
Postal code
36199-43189
Phone
+98 23 3220 1378
Email
sabafarhadi9675@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Yosef Kolokhi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Islamic Azad University of Shahroud, University Blvd
City
Shahrood
Province
Semnan
Postal code
36199-43189
Phone
+98 23 3222 7087
Email
dryousefkolookhianestezi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Farhadi
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Islamic Azad University of Shahroud, University Blvd
City
Shahrood
Province
Semnan
Postal code
36199-43189
Phone
+98 23 3220 1378
Email
sabafarhadi9675@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available